The meeting was attended by TSC members (Dr. Gerry Davies (UK), Prof. Charles Gilks (Australia), Prof. Guy Thwaites (UK/Vietnam), Dato’ Dr. Hj. Abdul Razak Muttalif (Malaysia), Dr. Sushil Pandey (Australia)), trial chief investigator Prof. Nick Paton (Singapore), MRC Clinical Trials Unit members Prof. Andrew Nunn (UK) and Dr. Patrick Phillips (UK), as well as other trial core members and collaborators. Trial sites were represented by Dr. Rovina Ruslami (Padjadjaran University, Indonesia) and Prof. Shenjie Tang (Beijing Chest Hospital, China).
The assembly discussed the trial protocol and drug regimens, data management and biostatistics, as well as trial logistics, organisation and community involvement matters.
TSC meetings will be held regularly until the completion of the trial in 2019.
TRUNCATE-TB (Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for drug-sensitive Tuberculosis) is a ground-breaking Phase 3 TB treatment regimen shortening trial, which will recruit over 1,000 patients in multiple Asian countries. The aim of this study is to determine whether a strategy of treating drug-sensitive TB for 2 months with novel combination regimens and re-treating relapses with a 6 month course of standard treatment will be non-inferior to the standard 6 month treatment / 6-month re-treatment approach.
The trial is sponsored by University College London (UCL) and funded by Medical Research Council (MRC)/Wellcome Trust/Department for International Development (DfID) (UK) and National Medical Research Council (NMRC) (Singapore). The trial will be managed by National University Singapore (NUS) and coordinated by Singapore Clinical Research Institute (SCRI).
TRUNCATE-TB is one of the key projects under SPRINT-TB's Theme 3.